Devices

FDA Neurological Regulator Joins Musk’s Neuralink

Former FDAer Daniel McMullen, who most recently was director of the CDRH Office of Neurological and Physical Medicine Devices, the agency unit responsible for the total lifecycle review of medical devices such as Neuralink’s brain implant, has joined Neuralink to lead its medical affairs division. The appointment was reported by Reuters, which says the appointment “calls into question the Trump administration’s promise to end the revolving door of government regulators moving into the private sector.”

The story says the move places a top government official inside Neuralink owner Elon Musk’s orbit after he led a government cost-cutting effort that included forcing out regulators overseeing his and other medical device companies.

McMullen has longtime ties to other Neuralink executives, Reuters says, having worked with them at a Duke University neuroscience lab. “This role combines scientific rigor, direct patient impact, and the chance to move the entire field of brain-computer interface forward,” McMullen was quoted as saying.

Neuralink reported in September that 12 people with severe paralysis worldwide have received its brain implants and are using them to control digital and physical tools through thought.

FDA initially rejected the company’s application for human trials in 2020 and approved it in 2024.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome